510(k) Report

FDA applicant

Arco Medical Products Co.

Mchenry, IL21 decisions1976–19800 recalls

FDA records 21 decisions for Arco Medical Products Co. (Mchenry, IL) from 1976 to 1980: 21 510(k) clearances. Most are in product codes DXY (Implantable Pacemaker Pulse-Generator) and DTD (Pacemaker Lead Adaptor). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Arco Medical Products Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Arco Medical Products Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Arco Medical Products Co. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Arco”

FDA records each applicant name separately; these may or may not be the same firm.